Transcript Essential medicines for children

'Hot topics'
ESSENTIAL MEDICINES FOR CHILDREN
Suzanne Hill
September 2006
What is the problem?
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Children are therapeutic orphans
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Lack of appropriate clinical trials
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Lack of licensed medicines
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Lack of formulations
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Lack of information
Initiatives so far concentrated on:
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Developed country regulatory structures (eg FDA, EMEA)
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Developed country drug information (eg BNF- C)
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HIV (eg new public private partnership)
For example…
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Creation of a Paediatric Committee at EMEA
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Requirements and Rewards/Incentives for medicinal products
still under patent, orphan drugs and for off-patent medicinal
products Paediatric Investigation Plans (PIP)
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Other measures
Patent-protected products
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Obligation to submit results of studies conducted according to agreed
Paediatric Investigation Plan (PIP) at time of marketing authorisation, or
variation (exclude generics)
If not: Invalid application for MA
$: 6-month extension of the patent protection (= Supplementary Protection
Certificate)
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For orphan drugs, + 2 yrs market exclusivity
Obvious gaps
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Essential medicines list – paediatrics
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Medicines for other diseases
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Formulations eg fixed dose combinations for malaria, TB
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Prescribing information
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Market incentives for appropriate drug development
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International regulatory standards, including quality
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International safety monitoring and post-marketing
surveillance
Work so far… HIV
Professor Tony Nunn, Liverpool
Current work with WHO
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Paediatric HIV dosing information
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From - mg/kg and mg/m2
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To - agreed weight bands
•
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with mg/m2 assigned to weight bands
Excel spreadsheets to examine closeness of fit to desired dose
•
limitation of
– weight banding and formulation
– solids preferred to liquids; half tablet?
– avoiding asymmetric 2 x daily dosing
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Present as ‘simple tables’
Simple table abacavir
What has been done so far…essential
medicines
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Review of current EML identifying paediatric gaps
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Preliminary applications for isoniazid 50mg, pyrazinamide
150mg, phenobarbitone injection, update on caffeine
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Post marketing surveillance proposal
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Preliminary survey of countries about paediatric
medicines, prices, guidelines, information
What has been done so far….UNICEF
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Global commitments include the Millennium
Development Goals, 'A World Fit For Children', Unite for
Children
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Surveys in countries about children's access to
medicines, both as part of the MICS and annual UNICEF
country report
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Dialogue with pharmaceutical industry around products
required for Child Survival (HIV-AIDS, Malaria, ARI,
diarrhoea, multimicronutrients)
Plan
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Work on a global project to make paediatric medicines a priority:
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Add missing essential formulations to the Model list in 2007; advise on
doses
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Update treatment guidelines
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Develop paediatric prescribing information – a formulary
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Develop effective methods for provision of information at the point of
care
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Collaborate with regulatory authorities to encourage appropriate drug
development and approval processes in all regulatory authorities
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Advocate for the development of paediatric medicines by the industry
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Develop quality standards for paediatric medicines
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Develop a system for enhancing safety monitoring of medicines in
children
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Provide guidance on procurement and supply of paediatric medicines